What is track and trace for Pharmaceuticals?
In the context of the pharmaceutical supply chain, track and trace refers to the process of determining a drug’s current and past locations. When track and trace is correctly implemented, a drug can be tracked throughout the supply chain and traced back up the supply chain upon return or recall.
In an effort to support track and trace for pharmaceuticals, serialization will be used to help identify a drug’s authenticity prior to sale, dispensing, return or recall. And, while a serial number provides a product with a unique identity, by itself, it is not enough to combat counterfeit, adulterated or expired medications from entering the drug supply chain. Serialized products must be supported by a number of other processes and data points, which are derived through track and trace. In the U.S. drug supply chain, those additional data points are supplied in the 3T data (transaction history, transaction statement, transaction information); and, in Europe those data points are aggregated into a master database, the European HUB (EU HUB) as well as country specific databases called National Medicines Verification System (NMVS).
Are pharmaceutical track and trace regulations as commonly implemented as serialization requirements?
Not every country with serialization requirements has track and trace requirements, but many countries are starting to implement track and trace paired with serialization to combat counterfeit, stolen or adulterated drugs. For instance, the U.S. is in the process of fully implementing the Drug Supply Chain Security act or DSCSA. The DSCSA details how the manufacturer must start the track and trace process through producing 3T data for drugs at the lot level. Every node within the supply chain from primary wholesalers and secondary wholesalers down to repackagers and dispensers must receive an electronic copy of the 3T data. They must also produce and add to the 3T data if they sell the product. Eventually, when all DSCSA requirements are fully implemented – recalled or returned drugs will be easily tracked back up through the supply chain.
What happens if traceability is not implemented?
In the U.S. and the E.U. companies that do not implement traceability procedures might face heavy fines, a bar on product launches, or loss of their drug licenses.
The FMD should be seen as a significant business continuity risk. The law is very clear: no data or wrong data means no sale.
In the U.S., wholesale distributors will not buy products that are not serialized or traceable, and manufacturers and repackagers run the risk of forfeiting their licenses if they do not serialize their products and initiate 3T. Finally, dispensers face similar risks if they accept and sell products lacking serial numbers and 3T data.
The decision to track and trace products is no longer an option, it is a requirement for companies wanting to do business in the United States and Europe.
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Headquartered in the United States, rfxcel is the leading cloud-based provider of serialization, and track and trace solutions. For over fifteen years, rfxcel has provided reliable and affordable solutions to meet global serialization and compliance requirements. With rfxcel’s relentless commitment to customer success and continuous innovation, companies can meet today’s compliance requirements and tomorrow’s business challenges.
rfxcel is the number one managed cloud company for Life Sciences. Everything rfxcel offers is managed by rfxcel not the customers. That’s because rfxcel believes:
- Commitment to customer success promises a prompt, full-service method of addressing customers’ serialization needs.
- Economies of scale are nice — but economies of expertise are even more valuable. The highest performance and cost-efficiency come when you combine infrastructure with specialized expertise and the exceptional customer service that we call HyperCare
- Every customer has easy access to engineers, project managers and experts to help with planning, architecting, building, and operations.
To learn more about track and trace for pharmaceuticals, contact rfxcel and speak to one of our specialists.